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RSS FeedPosted by Michael Wonder on 17 May 2021
AffyImmune Therapeutics' AIC100 granted fast track designation for treating thyroid cancer
17 May 2021 - AffyImmune Therapeutics announced today that the US FDA granted fast track designation to its lead compound, AIC100, ...
Posted by Michael Wonder on 17 May 2021
Statement on leronlimab
17 May 2021 - FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment ...
Posted by Michael Wonder on 17 May 2021
US Supreme Court denies Sandoz petition to review biosimilar Erelzi (etanercept-szzs) case
17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...
Posted by Michael Wonder on 17 May 2021
More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
17 May 2021 - EMA’s CHMP has recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine ...
Posted by Michael Wonder on 17 May 2021
Biogen hopes Alzheimer’s drug mired in controversy earns FDA nod
13 May 2021 - After scores of failures, regulators are set to rule on aducanumab, which promises to slow dementia. ...
Posted by Michael Wonder on 17 May 2021
TGA weighs over the counter contraceptive pill plan
17 May 2021 - The nation’s medicines regulator is looking at a plan to give Australians more freedom to access ...
Posted by Michael Wonder on 17 May 2021
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA for the treatment of opioid overdose
17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for ...
Posted by Michael Wonder on 17 May 2021
EMA publishes agenda for 17-20 May CHMP meeting
17 May 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 15 May 2021
Apellis announces U.S. FDA approval of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria
14 May 2021 - Empaveli was superior to Soliris for the change from baseline in haemoglobin level at Week 16 in ...
Posted by Michael Wonder on 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ...
Posted by Michael Wonder on 14 May 2021
Vaccine patent waivers deserve a warning label
13 May 2021 - The move to suspend patents on COVID-19 vaccines opens up a major risk to the way the ...
Posted by Michael Wonder on 14 May 2021
Molzym announces FDA breakthrough device designation for its molecular diagnostic test system – sepsis, ioint & implant infections, infective endocarditis, bacterial meningitis
10 May 2021 - Molzym’s unique technology for molecular microbial diagnostics was granted breakthrough device designation by the FDA in light ...
Posted by Michael Wonder on 13 May 2021
Pfizer warns that IP waiver for COVID-19 vaccines may invite ‘copycat medicines’
13 May 2021 - Company says removing intellectual property protections would make it ‘harder’ to make vaccines in the short term. ...
Posted by Michael Wonder on 13 May 2021
Strongbridge Biopharma announces U.S. FDA filing acceptance of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome
13 May 2021 - FDA Sets Prescription Drug User Fee Act target action date of 1 January 2022. ...